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CFR - Code of Federal Regulations Title 21

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[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2009]
[CITE: 21CFR314.98]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER D--DRUGS FOR HUMAN USE

PART 314 -- APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG

Subpart C--Abbreviated Applications

Sec. 314.98 Postmarketing reports.

(a) Except as provided in paragraph (b) of this section, each applicant having an approved abbreviated new drug application under 314.94 that is effective shall comply with the requirements of 314.80 regarding the reporting and recordkeeping of adverse drug experiences.

(b) Each applicant shall submit one copy of each report required under 314.80 to the Central Document Room, Center for Drug Evaluation and Research, Food and Drug Administration, 5901-B Ammendale Rd., Beltsville, MD 20705-1266.

(c) Each applicant shall make the reports required under 314.81 and section 505(k) of the act for each of its approved abbreviated applications.

[57 FR 17983, Apr. 28, 1992, as amended at 64 FR 401, Jan. 5, 1999; 74 FR 13113, Mar. 26, 2009]

 
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